Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: Federal University of Mato Grosso; Fiocruz Mato Grosso do Sul; National Institutes of Health (NIH)
• Treatments: Isoniazid

Criteria

Inclusion Criteria:

• Eligible for latent tuberculosis treatment by Brazil's national guidelines*

• provides written informed consent to participate in the study

Exclusion Criteria:

• Evidence of active tuberculosis or currently under evaluation for active tuberculosis

• Receiving drugs that interact with Rifapentine (e.g. methadone, warfarin)

• Known intolerance or hypersensitivity to isoniazid or rifapentine

• Prior treatment for active or latent tuberculosis > 14 days

• Close contact to isoniazid- or rifampicin-resistant tuberculosis (TB) case

• Neutropenia (absolute neutrophil count <1000 cells/mm3)

• Clinical diagnosis of active liver disease or alcohol dependence

• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal